Novex Innovations
Biologics & Tissue Division
Partnering with Novex Innovations: Supporting Your Biologic Program
Novex Innovations’ Biological and Tissue Division offers all-encompassing support for biologic programs, spanning from idea inception to product commercialization. Our capabilities include:
If you’re looking at transferring your program from another organization or moving a biological product from a development phase to the steps of commercialization, we have the resources to implement a plan that can accommodate your timelines.
Our tissue processing operations are carried out under cGMP to ensure the best possible control over your processing with clean air environments certified to ISO 5 standards.
Bioengineered human tissue and cell propagation are handled under regulated operational procedures, ensuring control and storage of cell lines for the reproducibility of manufacturing processes.
Using the generated development data, we create a development path geared to a commercial outcome. We leverage our internal process capabilities and our 3rd party analytical support for method development and release testing.
All operations are under cGMP manufacturing, ensuring the appropriate controls required specifically for your project. With our ISO 5 cleanrooms, we can manufacture under the appropriate level of environmental controls suited for your product/program.
From automation to manual operations, we support manufacturing from the smallest batch requirements to scaled-up requirements as your program grows.
We support all manufacturing activities from material evaluation to commercialization and every stage in between.
- FDA Registered (Offices of CBER).
- AATB Accredited
- ISO 13485 certified
- Manufacturer of several MET certified products
- QP certified for distribution of products in the European Union
- Undergoing internal review for PMDA accreditation.
- Currently registered as the sole manufacturer of numerous INDs for NDA / BLA applications.
The Unmatched Expertise of Novex Innovations in Biologics and Tissues
Novex Innovations offers a range of support options, from simple to complex development of biologic products, technology transfer, small batch to large-scale manufacturing, storage, distribution/shipping, and call services. From the initial idea inception to the final stages of product commercialization, we offer comprehensive services to fulfill all your needs.
By partnering with us, you gain access to our wealth of knowledge, experience, and resources, ensuring the success of your biologic program.
Customized Support: Choosing the Right Services for Your Objectives
Novex Innovations offers customized services tailored specifically to achieve our client’s development or manufacturing objectives. Our support can be all-encompassing, or you can select only the services you require to advance your project/program.
Customizable support from Novex allows researchers and developers to optimize their development processes, enhancing efficiency, quality, and success in delivering biological solutions to the market.
Frequently Asked Questions
Biologics are therapies that originate from living cells, tissue, or organisms, which have unique characteristics that influence the production, administration, and efficacy of treatment.
Biologics are molecules with complex structures that are produced by living systems. Traditional pharmaceuticals are typically chemically synthesized molecules that emulate or disrupt the biology of disease within a biological entity (human/animal). This makes biologics a distinct form of medicine compared to traditional pharmaceuticals.
Biologics manufacturing could involve complex fermentation, aseptic processing, stem cells, unique storage, and testing processes due to the delicate nature of biological macromolecules, proteins, and living cells, which all present numerous challenges.
The FDA approval process for biologics requires the submission of an Investigational New Drug (IND) Application. This will allow the agency to review pertinent data in support of pre-clinical, clinical, and testing studies to be performed which demonstrate safety, efficacy, and clinical benefit.
Prior to the approval of a Biologics License Application (BLA), a Pre-Approval inspection (PAI) of the manufacturing facility is completed to assess the adequacy and ensure the identity, strength, quality, and purity of the product can be maintained.
We are registered with the FDA through the office of CBER – HCT/P and accredited with AATB.
Novex Innovations can provide customized services to support biologic programs, including manufacturing, shipping, regulatory guidance, and development expertise.
Discover Our Other Divisions
Drug Division
From laboratory to commercial supply, Novex Solutions offers you the very best in biologic drug development and manufacturing services. We’re focused on delivering superior results every time. Enhanced by our cGMP standards and proven compliance track record, we’re an expert partner you can trust for biologic drugs, small molecule drugs, and other drugs.
Learn about our Drug Division.
Device Division
Our goal is to be a reliable ally in assisting with the design, development, and manufacturing of your devices.
Our team of experts collaborates with you to introduce your devices to the market successfully.
Learn about our Device Division.
Distribution Division
With a harmonious blend of manpower and automation, we craft inventory management and fulfillment options tailored to your needs.
From peak seasons to new product launches, we offer the flexibility needed to accommodate product inventory and distribution, all handled under your organization.
Learn about our Distribution Division.Looking for expert biologics and tissue solutions?
Biologic and tissue solutions hold immense potential in revolutionizing modern medicine. Their unique characteristics, complex development process, and targeted mechanisms of action set them apart from traditional pharmaceuticals. Overcoming manufacturing challenges and navigating the regulatory landscape are critical to ensuring the safety, efficacy, and commercialization of these groundbreaking therapies.
Partnering with Novex Innovations provides comprehensive and customizable support for biologic programs. By working closely with a reliable partner like Novex Innovations, researchers and developers can optimize their biologic development processes, ensuring the success of their programs and ultimately improving patient outcomes.
Our Biologics and Tissues Division is a reliable, experienced, and adaptive partner with expertise in biologics. Let’s start a conversation about what you need.
